A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

June 26, 2007 updated by: Nventa Biopharmaceuticals Corporation

A Phase II Trial of SGN-00101 In The Treatment of Pediatric Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's Hospital of Alabama
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • University of Arkansas for Medical Sciences, Arkansas Children's Hospital
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemour's Childrens Clinic, Division of Pediatric Oncology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Fairview University Medical Center, University of Minnesota
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas, Southwestern Medical School
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.
  • Patients with documented RRP
  • Subject is surgically debulked within 7 days before the first dose of SGN-00101.
  • Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries.
  • Subject is free of life threatening or serious concomitant disorders other than the disease under study.
  • Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator.

Exclusion Criteria:

  • Subject has disease or status that causes compromise of the immune system.
  • Subject has a history of ionizing radiation therapy to the respiratory tract.
  • Patient has used concomitant medications that may suppress the immune system.
  • Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study.
  • Subject has participated in a past study with SGN-00101
  • Pregnancy and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

June 4, 2002

First Submitted That Met QC Criteria

June 4, 2002

First Posted (Estimate)

June 5, 2002

Study Record Updates

Last Update Posted (Estimate)

June 27, 2007

Last Update Submitted That Met QC Criteria

June 26, 2007

Last Verified

June 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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